Implantable injection port with tissue in-growth promoter

ABSTRACT

A surgically implantable injection port has one or more tissue in-growth promoting surfaces. The injection port includes a housing, a fluid reservoir defined in part by the housing, a needle penetrable septum, and a tissue in-growth promoting surface integrally provided on an exterior surface of the port. The tissue in-growth promoting surface may be provided by surgical mesh or a textured surface on the injection port. The injection port may be used as part of a gastric band system or some other type of system.

BACKGROUND

Implantable medical devices may be implanted in a patient to perform atherapeutic function for that patient. Non-limiting examples of suchdevices include pace makers, injection ports (such as infusion ports aswell as ports used with gastric band systems), and gastric pacingdevices. Such implants may need to be attached, perhaps subcutaneously,in an appropriate place in order to function properly. It may bedesirable that the procedure to implant such devices be quick, easy andefficient.

Injection ports may be placed beneath the skin of a body for injectingfluids into the body, such as for infusing medication, blood draws, andmany other applications, including adjustable gastric band systems.Gastric band systems are operable to restrict the flow of food from theesophagus into the stomach. Some gastric bands include a fluid-filledelastomeric bladder with fixed endpoints that encircles the stomach justinferior to the gastro-esophageal junction. When fluid is added to thebladder, the band expands against the stomach, creating a food intakerestriction or stoma in the stomach. To decrease this restriction, fluidis removed from the bladder. Examples of gastric bands are disclosed inU.S. Pat. No. 7,416,528, entitled “Latching Device for Gastric Band,”issued Aug. 26, 2008, the disclosure of which is incorporated byreference herein. Another example of such an adjustable gastric band isdisclosed in U.S. Pat. No. 6,067,991, entitled “Mechanical Food IntakeRestriction Device,” issued May 30, 2000, the disclosure of which isincorporated by reference herein.

To the extent that an adjustable gastric band system includes aninjection port configured to receive the needle of a syringe assembly inorder to add or withdraw fluid to or from the gastric band, those ofordinary skill in the art will appreciate that it may be desirable insome settings to locate both the injection port and, more specifically,the center of the injection port (e.g., when the septum of the injectionport is at the center of the injection port). Locating the approximatecenter of the injection port with some degree of accuracy may facilitateaddition or withdrawal of fluid via the injection port to adjust thegastric band system. One example of a system and method for identifyingthe location of an injection port is disclosed in U.S. Pub. No.2006/0211914, entitled “System and Method for Determining ImplantedDevice Positioning and Obtaining Pressure Data” published Sep. 21, 2006,and issued Aug. 17, 2010 as U.S. Pat. No. 7,775,215, the disclosure ofwhich is incorporated by reference herein.

Those of ordinary skill in the art will appreciate that it may beadvantageous in certain circumstances to sense pressure, strain, and/orother parameters associated with operation of a gastric band device. Insome settings, it may be desirable to obtain data indicative of thepressure of fluid in a gastric band. Various examples of methods anddevices for obtaining pressure data and other types of data aredisclosed in U.S. Pub. No. 2006/0189888, entitled “Device forNon-Invasive Measurement of Fluid Pressure in an Adjustable RestrictionDevice,” published Aug. 24, 2006, and issued Apr. 20, 2010 as U.S. Pat.No. 7,699,770, the disclosure of which is incorporated by referenceherein. Additional examples of methods and devices for obtainingpressure data and other types of data are disclosed in U.S. Pub. No.2006/0199997, entitled “Monitoring of a Food Intake Restriction Device,”published Sep. 7, 2006, and issued Sep. 13, 2011 as U.S. Pat. No.8,016,745, the disclosure of which is incorporated by reference herein.Such parameter data may be obtained before, during, and/or afteradjustment of a gastric band, and may be useful for adjustment,diagnostic, monitoring, or other purposes, and may also be obtained withrespect to a mechanically actuated gastric band. In settings where afluid-filled gastric band is used, pressure data may be used todetermine whether the amount of fluid in the gastric band needs to beadjusted; and/or for other purposes.

While a variety of injection ports and gastric band systems have beenmade and used, it is believed that no one prior to the inventor(s) hasmade or used an invention as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a perspective view of an implantable portion of anexemplary gastric band system, including an injection port having atissue in-growth promoting surface;

FIG. 2 depicts a perspective view of the gastric band of FIG. 1, showingthe band positioned around the gastro-esophageal junction of a patient;

FIG. 3 depicts a cross-sectional view of the gastric band of FIG. 1,showing the band positioned around the gastro-esophageal junction of apatient in a deflated configuration;

FIG. 4 depicts a cross-sectional view of the gastric band of FIG. 1,showing the band positioned around the gastro-esophageal junction of apatient in an inflated configuration to create a food intakerestriction;

FIG. 5 depicts a perspective view of an exemplary alternative injectionport having a tissue in-growth promoting surface;

FIG. 6 depicts a side cross sectional view of the injection port of FIG.5;

FIG. 7 depicts an exploded perspective view of the injection port ofFIG. 5;

FIG. 8 depicts a perspective view of the bottom of the injection port ofFIG. 5, showing the fasteners in the extended/fired position;

FIG. 9 depicts an enlarged, fragmentary, exploded perspective view ofthe fitting and locking connector of the injection port of FIG. 5;

FIG. 10 depicts an enlarged, fragmentary partial cross-section view ofthe locking connector of FIG. 9 assembled to the fitting the septumretainer but not locked in place;

FIG. 11 depicts an enlarged, fragmentary partial cross-section viewsimilar to FIG. 10 showing the locking connector locked in place;

FIG. 12 depicts a perspective view of another exemplary alternativeinjection port having a tissue in-growth promoting surface;

FIG. 13 depicts a perspective view of the bottom of yet anotherexemplary alternative injection port having a tissue in-growth promotingsurface, showing the fasteners in the retracted/undeployed position;

FIG. 14 depicts a perspective view of the bottom of another exemplaryalternative injection port having a tissue in-growth promoting surface;

FIG. 15 depicts an exploded perspective view of another exemplaryalternative injection port having a tissue in-growth promoting surface;

FIG. 16 depicts a perspective view of the injection port of FIG. 15, inassembled form;

FIG. 17 depicts a perspective view of an exemplary tissue in-growthpromoting sleeve for use with an injection port;

FIG. 18 depicts a top plan view of an exemplary tissue in-growthpromoting sheath for use with an injection port;

FIG. 19 depicts a perspective view of the sheath of FIG. 18 mounted overan injection port;

FIG. 20 depicts a perspective view of an exemplary frame attachable toan injection port, with the frame including a tissue in-growth promotingsurface;

FIG. 21 depicts a cross-sectional view of the frame depicted in FIG. 20;

FIG. 22 depicts a side cross-sectional view of the frame of FIG. 20attached to an injection port;

FIG. 23 depicts a perspective view of an exemplary alternative frameattachable to an injection port, with the frame including a tissuein-growth promoting surface;

FIG. 24 depicts a perspective view of the bottom of an exemplaryinjection port configured for attachment of the frame of FIG. 23;

FIG. 25 depicts a side cross-sectional view of the frame of FIG. 23attached to the injection port of FIG. 24;

FIG. 26 depicts a perspective view of an exemplary surgical meshstructure configure for use with an injection port;

FIG. 27 depicts a perspective view of the surgical mesh structure ofFIG. 26 mounted on an exemplary injection port and associated fluidconduit;

FIG. 28 depicts a perspective view of an exemplary alternative surgicalmesh structure configured for use with an injection port;

FIG. 29 depicts a perspective view of the surgical mesh structure ofFIG. 28 mounted to an exemplary injection port and associated fluidconduit; and

FIG. 30 depicts a perspective view of an exemplary alternative frameattachable to an injection port, with the frame including tissuein-growth promoting surfaces.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. For example, while various examples ofports having tissue in-growth promoting surfaces and/or features aredepicted and described as being part of a gastric band system, thetissue in-growth surfaces and features may be employed with other typesof implantable medical ports or other medical devices. Accordingly, thedrawings and descriptions should be regarded as illustrative in natureand not restrictive.

I. Exemplary Gastric Band System

FIGS. 1-4 illustrate an exemplary gastric band system (10). As shown,gastric band system (10) comprises an injection port (12), a gastricband (20), and a flexible conduit (or catheter) (18). Injection port(12) of the present example comprises a port housing (13), a needlepenetrable septum (16) and a fluid reservoir (not shown in FIGS. 1-4)located beneath septum (16). Catheter (18) (e.g., a flexible polymerictube) is attached to port housing (13) in fluid communication with thefluid reservoir therein. A needle may pierce septum (16) to reach thereservoir and add or withdraw fluid (e.g., saline, etc.), as describedin greater detail below.

Port housing (13) may comprise a unitary structure (e.g., a one piecehousing insert molded about septum (16), etc.). Alternatively, porthousing (13) may be assembled from two or more mating components such asa port body that at least partially receives a port base therein (asfurther described herein). Port housing (13) may be formed of titanium,plastic, or any other suitable material or combination of materials.Septum (16) may be formed of silicone or any other suitable material orcombination of materials.

Injection port (12) of the present example also includes at least onetissue in-growth promoting surface (14), which extends about at least aportion of an outer surface of port housing (13). In some versions, andas further described herein, tissue in-growth promoting surface (14)comprises surgical mesh (e.g., polypropylene mesh) integrally providedon (e.g. bonded to) or adjacent to an outer surface of port housing(13), such as a peripheral sidewall of port housing (13) (as shown)and/or a bottom surface of port housing (13).

Injection port (12) may be subcutaneously secured over a patient'ssternum, to the patient's abdominal fascia, or in any other suitablelocation. In the present example, port (12) may be sutured in placeusing the suture apertures (15) located about the periphery of porthousing (13). It will be understood that the configuration of port (12)is merely exemplary of some possible versions. One or more tissuein-growth promoting surfaces may be provided on one or more portions ofany of a variety of injection ports, including ports configured to besutured in place as well as ports configured to be held in place usingone ore fasteners. By way of example only, an injection port having oneor more tissue in-growth promoting surfaces (e.g., mesh integrallyprovided on the port) may be configured and operable in accordance withthe teachings of U.S. Pat. No. 7,762,998, entitled “Implantable DeviceFastening System and Methods of Use,” issued Jul. 27, 2010, thedisclosure of which is incorporated by reference herein. In some otherversions, and as further described herein, injection port (12) may beconfigured and operable in accordance with the teachings of U.S. Pub.No. 2005/0283118, entitled “Implantable Medical Device with SimultaneousAttachment Mechanism and Method,” published Dec. 22, 2005, and issuedDec. 14, 2010 as U.S. Pat. No. 7,850,660, the disclosure of which isincorporated by reference herein. Alternatively, injection port (12) mayhave any other suitable configuration and/or operability.

Gastric band (20) of the present example comprises an inflatable bladder(22) that is secured to a flexible strap (24). Inflatable bladder (22)may be formed of silicone or any other suitable material or combinationof materials. Catheter (18) provides fluid communication between bladder(22) and the reservoir of injection port (12). Catheter (18) may beformed of silicone or any other suitable material or combination ofmaterials. In the present example, catheter (18), bladder (22), andinjection port (12) form a closed fluid circuit. Accordingly, a needlethat is inserted through septum (16) into the underlying reservoir maybe used to add fluid to or withdraw fluid from inflatable bladder (22)in order to adjust the restriction created by gastric band (20) asdescribed in greater detail below. In some versions, gastric band (20)is configured and operable in accordance with the teachings of U.S. Pat.No. 7,416,528, entitled “Latching Device for Gastric Band,” issued Aug.26, 2008, the disclosure of which is incorporated by reference herein.Alternatively, gastric band (20) may have any other suitableconfiguration and/or operability.

In some settings, gastric band (20) is applied about thegastro-esophageal junction of a patient. In particular, and as shown inFIG. 2, gastric band (20) is installed such that bladder (22) isadjacent to the tissue of the gastro-esophageal junction, with strap(24) on the outside of bladder (22). The ends of strap (24) are securedrelative to each other when gastric band (20) is sufficiently wrappedabout the patient's stomach (2). While strap (24) is flexible in thisexample, strap (24) substantially resists stretching along its length.Accordingly, when fluid is added to bladder (22) (e.g., using a needleinserted through septum (16) of injection port (12), etc.), bladder (22)expands and exerts inward forces on the gastro-esophageal junction ofthe patient. This reduces the size of the internal stoma at thegastro-esophageal junction, thereby creating a restriction on foodintake into the patient's stomach (2). It should be understood that thesize of this stoma may be decreased by adding more fluid to bladder (22)to create a greater degree of restriction, or increased by withdrawingfluid from bladder (22) to reduce the degree of restriction.

As shown in FIGS. 2-4, an installed gastric band (20) at leastsubstantially encompasses the upper portion of stomach (2) near thejunction with esophagus (4) in the present example. FIG. 3 shows gastricband (20) in a deflated configuration, where bladder (22) containslittle to no fluid, thereby maximizing the size of the stoma openinginto stomach (2). FIG. 4 shows gastric band (20) in an inflated,fluid-filled configuration, where bladder (22) contains substantiallymore fluid than is shown in FIG. 3. In this configuration shown in FIG.4, the pressure of gastric band (20) against stomach (2) is increaseddue to the fluid within bladder (22), thereby decreasing the stomaopening to create a food intake restriction. FIG. 4 also schematicallyillustrates the dilation of esophagus (4) above gastric band (20) toform an upper pouch (6) beneath the diaphragm muscle (8) of the patient.

As mentioned previously, injection port (12) may be subcutaneouslysecured over a patient's sternum, to the patient's abdominal fascia, orin any other suitable location. While injection port (12) may be securedin place by integral fasteners, sutures, or other fastening members (orany combination of one or more of the foregoing), injection port (12)may become dislodged or otherwise displaced from its original locationafter implantation in some instances. In addition, injection port (12)may be mobile, making it difficult to insert a needle through the septum(16) in order to add or remove fluid. Also, catheter (18) may becomedetached from injection port (12), potentially allowing fluid to leakfrom bladder (22) and/or the fluid reservoir within injection port (12),or at least cutting off fluid communication from injection port (12) tobladder (22).

In order to help reduce the likelihood of (if not prevent) dislodgementor displacement of injection port (12), limit the mobility of injectionport (12), and/or prevent detachment of catheter (18) from injectionport (12), one of more tissue in-growth promoting surfaces may beprovided on, or associated with, injection port (12) and/or catheter(18). In the example shown in FIG. 1, a tissue in-growth promotingsurface comprising surgical mesh (14) is integrally provided on an outersurface of port housing (13). As used herein, the phrase “integrallyprovided on” simply means that the surgical mesh generally cannot beremoved from the port without damaging the mesh or, in some versions,disassembling the injection port (e.g., in the case of surgical meshmounted within the port, etc.). Following implantation of port (12),tissue surrounding port (12) may grow into surgical mesh (14) (e.g.,into the openings between adjacent fibers and around the fibers of themesh, etc.). Such tissue in-growth may assist in retaining port (12) inplace and limiting the mobility of port (12).

Surgical mesh (14), as well as the surgical mesh used in other examplesdescribed herein, may be formed from any biologically-compatible, porousmedical textile, and/or open-matrix material suitable for implantationin a patient. Such materials may be similar to those used forreinforcing tissue defects, such as mesh slings used for hernia repair.The surgical mesh may comprise, for example, synthetic and/ornaturally-derived filaments or wires that are woven, knitted, molded, orotherwise formed into a porous mesh or open-matrix structure that actsas a lattice allowing tissue in-growth between and/or around thefilaments or wires. Suitable surgical mesh materials may include, forexample, knitted polypropylene mesh fabrics such as those available fromEthicon, Inc. under the Prolene, Vicryl and Panacryl trademarks. Othersuitable materials include, for example, a mesh or open-matrix structureformed of stainless steel, titanium, or other metal filaments or wiressuitable for implantation. It should also be noted that the surgicalmesh may be manufactured from two or more different materials, such asmesh having both non-absorbable and absorbable filaments for furtherpromoting tissue in-growth. Various other suitable materials,combinations of materials, and configurations that may be used for asurgical mesh will be apparent to those of ordinary skill in the art inview of the teachings herein.

II. Injection Port with Tissue in-Growth Promoting Feature

A. Tissue in-Growth Promoting Material Bonded to One or More PortSurfaces

FIGS. 5-11 show an alternative injection port (26) suitable for use, forexample, as part of a gastric band system. Injection port (26) includesone example of a tissue in-growth promoting surface integrally providedon the injection port. Although the tissue in-growth promoting featuresare illustrated in the figures as being embodied in or associated withinjection port (26), the tissue in-growth promoting features describedherein may be used with any implantable medical device for which it issuited, including by way of example only pacemakers, other types ofimplantable injection ports (such as vascular access ports), and gastricpacing devices. It should be noted that injection port (26) is similarin construction to the port depicted and described in U.S. Pub. No.2005/0283118, issued as U.S. Pat. No. 7,850,660, and additional detailsconcerning the construction and operation of port (26) may be providedin accordance with the teachings of U.S. Pub. No. 2005/0283118, issuedas U.S. Pat. No. 7,850,660. Of course the tissue in-growth promotingfeatures shown in FIGS. 5-11 may alternatively be provided on any othertype of injection port suitable for implantation in a patient.

Injection port (26) includes septum (28), as well as a port housingcomprising port base (30), port body (32), and actuator (36). Port base(30) acts as a retainer for septum (28) and is configured to nest atleast partially within port body (32) such that septum (28) iscompressed between port base (30) and port body (32). As furtherdescribed herein, a fluid reservoir (58) is defined by port base (30)beneath septum (28).

As best seen in FIGS. 7 and 8, injection port (26) also includes one ormore fasteners (34) for securing injection port (26) subcutaneouslywithin a patient. As further described in detail in U.S. Pub. No.2005/0283118, issued as U.S. Pat. No. 7,850,660, rotation of actuator(36) with respect to port body (32) may be used to deploy the fasteners(34) so as to secure port (26) in place. Fasteners rotate within portbody (32) so as to be deployed through slots in the bottom surface ofport body (32), as shown in FIG. 8.

It will be understood that the construction of injection port (26) ismerely exemplary of one possible version. For example, the injectionport may be greatly simplified to include a port body (or housing)configured to retain a septum, and having a fluid reservoir (or chamber)located beneath the septum, and a catheter may be attached to theinjection port in fluid communication with the fluid reservoir (e.g.,similar in construction to port (12) in FIG. 1, etc.).

As seen in FIGS. 6 and 7, septum (28), which may be made of any suitablebiocompatible material such as silicone, is disposed partially withininternal cavity (40) of port base (30), adjacent annular flat (42). Portbase (30), port body (32), and actuator (36) may be made of any suitablebiocompatible material having sufficient stiffness and strength, such aspolyether ether ketone (known as PEEK) or other plastic suitable forimplantation in a patient. Fasteners (34) may be made of any suitablebiocompatible material, such as stainless steel.

Port body (32) includes annular rim (44), which engages the uppersurface of septum (28) about an annular portion. Port body (32) isretained to port base (30) by a plurality of pins (46), which aredisposed through respective holes (48) formed in recesses (50) in portbody (32) and which extend inwardly into respective recesses (52) formedabout the bottom periphery of port base (30). Pins (46) may be made ofany suitable biocompatible material, such as stainless steel. When port(26) is assembled as shown, septum (28) is sufficiently compressedbetween port base (30) and port body (32) so as to be adequatelyself-healing and thus maintain a fluid tight system under pressure evenafter multiple penetrations by a needle.

Plate (54) is disposed in recess (56) formed in the bottom of port base(30), underlying septum (28) and fluid reservoir (58). As seen in FIG.6, plate (54) does not contact the sidewall (60) that defines the outerperiphery of fluid reservoir (58). When a needle is inserted throughseptum (28) to introduce or withdraw fluid from fluid reservoir (58),such as in order to adjust the size of an adjustable gastric band, plate(54) will protect port base (30) from puncture and provide tactilefeedback to the surgeon (through the needle) indicating that the needlehas bottomed in reservoir (58). Plate (54) may be secured to port base(30) in any suitable manner.

Port base (30) includes passageway (62), in fluid communication withfluid reservoir (58), which is defined by tubular fitting (64) extendingfrom the periphery adjacent the bottom of port base (30). Fluid conduitor catheter (18), which leads to adjustable gastric band (20), isconnected to fitting (64), being compressingly urged against annular rib(66) by connector (68), which is disposed about catheter (18) andsecured to port body (32). Sleeve (70) is disposed about catheter (18),secured to connector (68) by annular ribs (72). Sleeve (70) relievesstrain on catheter (18), substantially preventing catheter (18) fromkinking when loaded laterally.

Actuator (36) is rotatably secured to port body (32). Although in thepresent example actuator (36) is illustrated as an annular ringrotatably supported by port body (32), actuator (36) may be any suitableconfiguration and supported in any suitable manner to permit actuator(36) to function to move fasteners (34) between and including deployedand undeployed positions. As seen in FIG. 7, port body (32) includes aplurality of downwardly and outwardly extending tabs (74). In thepresent example, there are four equally spaced tabs (74). Actuator (36)includes an equal number of corresponding recesses (76), each having anarcuate bottom (78). To assemble actuator (36) to port body (32),recesses (76) are aligned with tabs (74), and actuator (36) is thenpushed down, temporarily deflecting tabs (74) inwardly until tabs (74)reach recesses (76) and move outwardly to dispose lower edges (74 a) inrecesses (76) such that actuator (36) is retained thereby. The lengthsof tabs (74) and depth of recesses (76) allow some axial end playbetween actuator (36) and port body (32) in the present example.

Actuator (36) may rotate generally about the central axis of port body(32). In the present example, actuator (36) may rotate through an angleof about 40 degrees, although any suitable angle may be used. Also inthe present example, when actuator (36) is rotated in the deployingdirection, fasteners (34) move to the deployed position shown in FIG. 8.

A detent system is formed by a pair of spaced apart raised detent ribs(76 a, 76 b) extending inwardly from the wall of each recess (76) and acorresponding raised rib (74 b) extending outwardly from tab (74). Thedetent system assists in preventing actuator (36) from rotation andfasteners (34) from moving out of fully retracted or fully extendedfired states under vibration or incidental loads, as described in U.S.Pub. 2005/0283118, issued as U.S. Pat. No. 7,850,660. To actuate theattachment mechanism, actuator (36) is rotated in a deploying direction,which in the present example is depicted as clockwise, though any othersuitable direction configured to actuate an attachment mechanism may beused.

Actuator (36) further includes a plurality of spaced apart openings orslots (80), which may be engaged by any suitable instrument to transmitthe necessary torque to rotate actuator (36) so as to extend fasteners(34) to the actuated position shown in FIG. 8. Slots (80) may beconfigured to be engaged by commercially available instruments,rectangular in the embodiment depicted, or by a dedicated applier suchas that shown and described in U.S. Pub. No. 2005/0283118, issued asU.S. Pat. No. 7,850,660. Port body (32) of the present example includesa plurality of recesses (82) disposed about its lower periphery that areconfigured to cooperate with the dedicated applier, as further describedin U.S. Pub. 2005/0283118, issued as U.S. Pat. No. 7,850,660.

Referring to FIG. 8, port base (30) includes a plurality of locatingtabs (84) extending outwardly from adjacent the bottom periphery of portbase (30). Locating tab (84 a) may be integral with fitting (64). Portbase (30) is inserted into the open bottom end of port body (32) suchthat tabs (84 and 84 a) are located in respective complementarily shapedrecesses (86) formed in the inner surface of port body (32), thusaligning port base (30) properly within port body (32). As furtherdescribed in U.S. Pub. No. 2005/0283118, issued as U.S. Pat. No.7,850,660, one or more apertures extending through actuator (36) andport body (32) may be provided, and these apertures may be used by thesurgeon to suture injection port (26) subcutaneously in a patient,particularly if the integral attachment mechanism (e.g., fasteners (34))is not used.

FIGS. 9-11 illustrate the locking connection between connector (68) andport body (32). FIG. 9 is an exploded perspective view showing fitting(64) partially surrounded by extension (88). FIG. 10 shows extension(88) in cross-section, with connector (68) generally disposed aboutfitting (64) and catheter (18) aligned in circumferential slot (88 c) ofextension (88). Connector (68) includes a pair of tabs (68 a, 68 b)extending outwardly therefrom. To assemble, connector (68) is guidedalong catheter (18) and fitting (64), with tabs (68 a, 68 b) alignedwith openings (88 a, 88 b) of extension (88). With tabs (68 a, 68 b)aligned with circumferential slot (88 c), connector (68) is rotated tolock it in place. During rotation, detent edge (88 d) createsinterference opposing the rotation of tab (68 a), but is dimensioned toallow tab (68 a) to be rotated past, to the locked position seen in FIG.11.

While fasteners (34) and/or sutures may be used to subcutaneously secureport (26) in a patient, the example of port (26) shown in FIG. 5 alsoincludes a plurality of tissue in-growth promoting surfaces. In some ofthe various examples shown and described further herein, one or moretissue in-growth promoting surfaces are provided on one or more exteriorsurfaces or portions of injection port (26). By way of example, thetissue in-growth promoting surface may comprise a tissue in-growthpromoting material integrally provided on (e.g. bonded) to one or moreregions of injection port (26). Alternatively, or in addition thereto,the tissue in-growth promoting surface may comprise one or more regionsof injection port (26) that are textured or otherwise configured so asto promote tissue in-growth on and in such surface.

Suitable tissue in-growth promoting materials that may be affixed to oneor more regions of injection port (26) so as to provide a tissuein-growth promoting surface may include, for example, biocompatiblesurgical mesh comprising a porous medical textile or open-matrixstructure that acts as a lattice for tissue in-growth. The mesh maycomprise, for example, synthetic and/or naturally-derived fibers,filaments, or wires that are woven, knitted, molded, or otherwise formedinto a porous mesh or open-matrix structure that allows tissue growthbetween and/or around the fibers, filaments, or wires. Suitablepolymeric materials for such mesh may include polypropylene mesh. Othersuitable materials may include, for example, mesh made from stainlesssteel, titanium, and/or other metal filaments suitable for implantation.Any of a variety of mesh shapes and sizes may be employed. As furthernoted herein, surgical mesh of more than one mesh size and/or densitymay even be employed. In addition, the mesh may be made from two or moredifferent types of fibers, filaments, or wires, such as mesh having bothabsorbable and non-absorbable filaments.

In the example shown in FIGS. 5-8, injection port (26) includes tissuein-growth promoting surfaces comprising biocompatible surgical mesh (90)affixed about a portion of the peripheral sidewall of port body (32). Inthe example shown, four sections of mesh (90) are provided. However, anynumber of sections of polypropylene mesh (90) may be provided onportions of the peripheral sidewall of port body (32) and/or on one ormore other surfaces of port (26). Mesh (90) is configured so as not tointerfere with the assembly or operation of injection port (26). Thus,in the example shown, each section of surgical mesh (90) comprises anarcuate strip with a cutout region (112) shaped and located so as toextend around the periphery of recess (50) (see FIG. 5). Of course itwill be understood that any of a variety of shapes and sizes of mesh maybe affixed to one or more outer surfaces of port (26).

Surgical mesh (e.g., polypropylene mesh) (90) may be permanently bondedto (i.e., integrally provided on) port body (32) in any of a variety ofways. For example, mesh (90) may be bonded to port body (32) using abicopompatible adhesive (e.g., isocyanate or cyanoacrylate adhesive),heat staking, vibration welding, ultrasonic welding, hot/cold upset,mechanical attachments (e.g., interference fits, hooks, barbs, sutures,clamps, clips, etc.), and other ways known in the art. In the exampleshown, mesh (90) is bonded to the periphery of port body (32) using anadhesive.

Mesh (90) may be bonded to port (26) across substantially the entireunder surface of mesh (90) (e.g., by a layer of adhesive between mesh(90) and port body (32), etc.). Alternatively, mesh (90) may beselectively bonded to port body (32) at one or more points or regions soas to provide one or more regions of mesh (90) that are not affixed toport (26). By way of example, mesh (90) may be bonded about its outerperimeter to port body (26) by heat staking such that the region of mesh(90) interior of its outer perimeter remains unattached to port body(32). Such unattached regions may allow additional tissue in-growthbetween mesh (90) and the wall of port body (32), particularly tissuein-growth around individual fibers of polypropylene mesh (90), thusfurther securing injection port (26) in place.

It will be understood that any number of sections of mesh (90) may beprovided on injection port (26), attached to any of a variety ofsurfaces and locations. For example, mesh may be provided on theundersurface of port base (30), such as in the form of a circular meshdisc centrally located on the bottom surface of port base (30). The meshdisc may even extend over slots (38) in the bottom surface of port body(32), provided that the mesh is sufficiently thin so as to be penetratedby fasteners (34) when the fasteners (34) are deployed. Alternatively,or in addition thereto, mesh may be affixed about the upper surface ofactuator (36), such as a plurality of arcuate strips arrayed about theupper surface of actuator (36) adjacent the outer circumference ofseptum (28).

Mesh or other tissue in-growth promoting material also may be affixedover top of septum (28), such as in the form of a round disc of meshbonded or otherwise affixed to the outer surface of port base (30) orport body (32) adjacent septum (28) and/or affixed directly to the uppersurface of septum (28) (e.g., using an adhesive). Provided that the meshor other material is not too thick or dense, the mesh may be easilypenetrated by a needle to allow the needle to be advanced through septum(28) in order to, for example, add or withdraw fluid from a gastric bandsystem. Other suitable configurations and locations that may be used formesh or any other suitable kind of mesh or similar structure will beapparent to those of ordinary skill in the art in view of the teachingsherein.

B. Tissue in-Growth Promoting Material Bonded to Textured Port Surface

The area of injection port (26) to which the mesh (90) is attached mayalso be configured to further promote tissue in-growth. For example, theregion(s) of the peripheral surface of port body (32) covered by mesh(90) may be textured so as to further promote tissue-in-growth. Suchtexturing may comprise, for example, a plurality of recesses, apertures,interconnected pores (e.g., a porous surface), ridges, protuberances(e.g., a roughened surface), trabeculae, or a combination of one or moreof these features. Such features may provide areas where the mesh isspaced away from the surface of the injection port, thus allowing tissueto grow into the mesh and around the fibers of the mesh (e.g., tissuein-growth between portions of the mesh and the surface of the port towhich the mesh is attached).

By way of example, the region of the peripheral surface of the injectionport covered by surgical mesh (or other tissue in-growth promotingmaterial) may include one or more recesses that are covered by the mesh.In this manner, tissue is able to grow through the openings in the mesh,into the recess(es), around individual fibers of the mesh, and back outother openings in the mesh into adjacent tissue. An example of such aconfiguration is shown in FIG. 12, where mesh (90) has been partiallycut-away to reveal an array of recesses (94) in the peripheral surfaceof port body (32). Recesses (94) are located so as to be covered by mesh(90). Such recesses (94) allow for tissue in-growth not only intorecesses (94) but also around the individual fibers of mesh (90). Ofcourse, recesses (94) are merely exemplary of one contemplated version.Recesses of any of a variety of size, shape, number, arrangement, andlocation may be provided beneath mesh (90), adjacent to mesh, orelsewhere. For example, mesh (90) may be affixed to port (26) over asingle recessed area such that mesh (90) is spaced away from the bottomof the recessed area.

C. Tissue in-Growth Promoting Surface(s) Integrally Provided onInjection Port

In place of bonding one or more tissue in-growth promoting materials tosurfaces of injection port (26) (or in addition thereto), a tissuein-growth promoting surface may be integrally provided on one or moreportions of injection port (26), such as by molding and the like. By wayof example, a textured tissue in-growth promoting surface such asdescribed previously may be formed (e.g., molded) on one or moresurfaces of the injection port. As yet another alternative, one or morecomponents of the injection port may be insert molded about one or moremesh layers or other porous layers. Some examples of such integralfeatures will be discussed in greater detail below, while other exampleswill be apparent to those of ordinary skill in the art in view of theteachings herein.

1. Integral Mesh Layer on Port

In the example shown in FIG. 13, a mesh layer (94) is integrallyprovided adjacent the bottom surface of port base (30). In the exampledepicted, port base (30) is insert molded about mesh layer (94), whichmay comprise, for example, a surgical mesh of the type describedpreviously. As another merely illustrative example, mesh layer (94) maycomprise a substantially rigid plastic screen (e.g., PEEK, polysulfone,polyethylene, or other implant-grade material). In addition, mesh layer(94) may have openings of any of a variety of shapes, sizes and number.While the depicted example has rectangular openings, other shapes suchas circular openings may be provided instead (or in addition thereto).Mesh layer (94) may be located within a circular cavity (96) formed inthe bottom surface of port base (30). In the present example, the bottomsurface (98) of cavity (96) is spaced away from mesh layer (94) so as toallow for greater tissue in-growth around the mesh. Of course such meshlayers may be integrally provided adjacent any of a variety of surfacesof injection port (26) (e.g., the sidewall of port body (32)), in asimilar fashion or otherwise. In addition, any of a variety of othertissue in-growth promoting materials may be integrally provided adjacentone or more surfaces of the injection port (e.g., by insert molding andthe like).

2. Textured Tissue in-Growth Promoting Surface

As yet another merely illustrative alternative, one or more surfaces ofan injection port may be textured so as to promote tissue-in-growth.Such texturing may comprise, for example, a plurality of recesses,apertures, interconnected pores (e.g., a porous surface), ridges,protuberances (e.g., a roughened surface), trabeculae, or a combinationof two or more of these features. Such texturing may provide areas fortissue in-growth, such as into recesses, apertures, or pores, and/orbetween ridges, other protuberances, or trabeculae, etc.

By way of example, and as shown in FIG. 14, a surface of the injectionport is formed (e.g., molded) so as to include a plurality of recessesfor promoting tissue growth into the recesses to assist in securing theport within a patient. In this particular embodiment, the bottom surfaceof port base (30) has been molded so as to include an array of recesses(100). The bottom surface of recesses (100) may also be textured (e.g.,ridges or protuberances, etc.) to further promote tissue in-growth. Onethe injection port is implanted in a patient, tissue is able to growinto the recesses (100) in the bottom surface of port base (30). Ofcourse, recesses of any of a variety of sizes, shapes, number,arrangements, and locations may be provided on one or more surfaces ofthe injection port.

D. Tissue in-Growth Promoting Material Mounted at Least Partially WithinInjection Port

As an alternative (or in addition) to bonding surgical mesh to one ormore surfaces of the injection port or insert molding portions of theinjection port around a mesh layer, a layer of biocompatible mesh (e.g.,polypropylene mesh, etc.) may be mounted at least partially within theinjection port such that one or more portions of the mesh are exposedfor promoting tissue in-growth. One or more mesh layers may be mountedwithin the injection port, for example, by positioning at least aportion of the mesh between two port components that are secured to oneanother.

In the example shown in FIGS. 15-16, a disc-shaped layer of mesh (102)is positioned between port base (30) and port body (32), directly aboveseptum (28). When port base (30) is mounted within port body (32) in themanner described previously, mesh (102) will be trapped between portbase (30) and port body (32) with a center portion (104) of mesh (102)overlying septum (28). As best seen in FIG. 16, mesh (102) is sized suchthat when trapped between port base (30) and port body (32), a portion(108) of mesh (102) extends outward of the injection port around thelower periphery of port body (32). When the injection port of FIGS.15-16 is implanted in a patient, center portion (104) of mesh (102) aswell as the portion (108) of mesh (102) extending outwardly away fromthe perimeter of port body (102) will be exposed such that tissue maygrow into and around these exposed portions of mesh (102). Also, theexposed portion (108) of mesh (102) extending away from port body (32)may be used to further secure the port within a patient, such as bysuturing or tacking exposed portion (108) to the fascia or other tissuein the patient.

As also shown in FIG. 15, mesh layer (102) is configured to have regionsof varying density (in terms of weight, mesh size, and/or thickness). Inthe example shown, center portion (104) has a greater density than outerannular portion (106). Since center portion (104) overlies septum (28)when the injection port is assembled, the increased density of centerportion (104) provides tactile feedback for locating septum (28) (byfeel, through the patient's skin) and/or detecting that a needle haspenetrated septum (28).

As an alternative to center portion (104) of mesh (102) having a greaterdensity, outer annular portion (106) may be configured to have a greaterdensity than center portion (104). This may be desirable in order toprovide greater structural integrity in mesh (102) (e.g., to preventtearing of mesh (102)), without inhibiting needle penetration throughcenter portion (104). Center portion (104) of mesh (102) may even beeliminated entirely such that surgical mesh (102) forms an annulus. Inthis arrangement, septum (28), or at least a center portion thereof,will not be covered by mesh (102).

While mesh (102) in FIGS. 15-16 is positioned between port base (30) andport body (32) above septum (28), one or more surgical mesh layers maybe mounted at least partially within other locations of the injectionport. By way of example, a mesh layer similar to mesh (102) may bepositioned between septum (28) and port base (30), and/or between portbody (32) and actuator (36), with at least a portion of the mesh exposedin order to promote tissue growth into and around the mesh layer.

III. Tissue in-Growth Promoter Attachable to Injection Port

A. Sleeve Made from Tissue in-Growth Promoting Material

FIG. 17 depicts another merely illustrative example for promoting tissuein-growth in order to secure an injection port within a patient. In thisexample, a sleeve (or pouch) (110) made of a tissue in-growth promotingmaterial is provided. Sleeve (110) is sized and configured such thatinjection port (28) may be inserted therein through open end (112).Sleeve (110) may be made of any of the variety of tissue in-growthpromoting materials described previously, such as a surgical mesh. Inthe example shown, sleeve (110) comprises polypropylene mesh. The meshused in forming sleeve (110) is of sufficient density to providestructural integrity while still allowing the injection port to besecured within a patient in any of the ways previously discussed (e.g.,fasteners, sutures, etc.). If desired, sleeve (110) may have one or moreapertures or other openings located to be positioned over features onthe injection port that facilitate securing the port within a patient(e.g., apertures positionable over slots (80) on actuator (36) so as toallow the use of an applier to rotate the actuator and deploy fasteners(34), etc.).

After the injection port is inserted into sleeve (110), the sleeve (110)may be secured to the injection port in any of a variety of ways. Forexample, the open end (112) of sleeve (110) may be secured about sleeve(70) of injection port (28) and/or catheter (18) simply by tying asuture about open end (112). As another merely illustrative example,open end (112) may include a drawstring or similar feature.Alternatively, sleeve (110) may be secured to injection port (28) usinga biocompatible adhesive, heat staking, vibration welding, ultrasonicwelding, and other ways known in the art. In the present example, afterinjection port (28) is inserted into open end (112) of sleeve (110),sleeve (110) is heat shrunk about port (28).

If mesh sleeve (110) is sufficiently large, when injection port (28)with attached catheter (18) is inserted into sleeve (110) a portion ofsleeve (70) or even catheter (18) may be located within mesh sleeve(110). In this manner, mesh sleeve (110) may also be secured to sleeve(70) and/or a portion of catheter (18). When implanted, tissue will growinto and around the portion of mesh sleeve (110) covering sleeve (70)and/or catheter (18), thereby reducing the likelihood of (if notpreventing) catheter (18) becoming disconnected from injection port(28).

Sleeve (110) may further be configured to have one or more regions ofvarying density, similar to mesh layer (102) in FIG. 15. Thus, sleeve(110) may have a region of greater or lower density located so as to bepositionable over septum (28) when injection port (26) is inserted intosleeve (110). As yet another alternative, sleeve (110) may include anaperture located so as to be positionable over septum (28) such thatseptum (28) remains fully exposed after injection port (26) is insertedinto sleeve (110). Other suitable configurations for sleeve (110) willbe apparent to those of ordinary skill in the art in view of theteachings herein.

B. Sheath Made from Tissue in-Growth Promoting Material

FIGS. 18-19 depict an example comprising a sheath (114) made of a tissuein-growth promoting material such as surgical mesh. Sheath (114) isconfigured to be draped over injection port (26), particularly after theinjection port has been positioned or secured in a patient. Sheath (114)includes a first portion (116) configured to be draped over injectionport (26), and a second portion (118) configured to be draped over aportion of catheter (18). In the example shown, first portion (116) hasa generally circular shape corresponding to the shape of injection port(26). It should be kept in mind, however, that a variety of other shapesmay be employed for first portion (116) of sheath (114).

First portion (116) also includes an aperture (120) configured andlocated such that, when first portion (116) is draped over injectionport (26), septum (26) is exposed through aperture (120) (see FIG. 19).In some other versions, first portion (116) of sheath (114) may beconfigured similar to mesh disc (102) shown in FIG. 15 such thataperture (120) is replaced by a center portion of mesh having adifferent density than an outer annular portion.

Sheath (114) may be draped over injection port (28) before or after theinjection port is positioned within a patient. If draped over injectionport (28) before the port is positioned within a patient, sheath (114)may be secured to the injection port using, for example, an adhesive.Alternatively, injection port (28) may first be positioned within apatient, and the port even secured in place (e.g., using fasteners (34),etc.), before sheath (114) is draped over the injection port.Thereafter, sheath (114) may be secured in place over injection port(28), such as by sutures (122). Sutures (122) may be used to attachsheath (114) to tissue surrounding implanted port (28), as shown in FIG.19. Of course any of a variety of other fasteners may be used in placeof, or in addition to, sutures (122), such as surgical tacks, staplesand the like.

Second portion (118) of sheath (114) extends radially away from firstportion (116), and is configured to drape over a portion of catheter(18). In the example shown in FIG. 19, second portion (118) extends overa portion of sleeve (70) through which catheter (18) extends. It will beunderstood that second portion (118) may be configured so as to extendover not only sleeve (70) but also a portion of catheter (18) locateddistally of sleeve (70). Second portion (118) may be secured over or tocatheter (18) and sleeve (70) by any of a variety of means, such assutures (122).

When sheath (114) is positioned over injection port (28) within apatient, tissue surrounding the implantation site may grow into andaround the mesh of sheath (114), helping to retain port (28) in itsproper location. In addition, second portion (118) of sheath (114) mayhelp substantially prevent catheter (18) from becoming disconnected fromport (28). While second portion (118) may be omitted, second portion(118) may also help prevent inadvertent puncture of or other damage tocatheter (18), particularly if sheath (114) or at least second portion(118) is made of a mesh or other material having sufficient strengthand/or density.

C. Attachable Housing Having Tissue in-Growth Promoting Surface

As an alternative to providing tissue in-growth promoting surfaces onthe injection port, or in addition thereto, one or more tissue in-growthpromoting surfaces may be provided on a frame attachable to theinjection port. Such an attachable frame may be configured to beattached to the injection port by the surgeon (e.g., as an adapter,etc.), thus allowing the surgeon to determine whether or not tissuein-growth promotion is desired. An injection port may even be suppliedwith multiple frames, each of which has different types, locations andor other characteristics of tissue in-growth promoting surfaces. Forexample, one frame when attached to the injection port may provide atissue in-growth promoting surface beneath the injection port, whileanother frame may be configured to provide tissue in-growth promotingsurfaces both beneath and around the periphery of the injection portwhen attached thereto. Such frames may be configured to be attached tothe injection port in any of a variety of ways, such as snap-fit over aportion of the injection port and/or the use of various fasteners suchas a hook and loop fastener arrangement. Merely illustrative examples ofsuch frames will be described in greater detail below, while othersuitable versions of such frames will be apparent to those of ordinaryskill in the art in view of the teachings herein.

1. Frame Configured for Snap-Fit onto Injection Port

FIGS. 20-22 depict another example of a tissue in-growth promotingsurface for use with an injection port. In this example, the tissuein-growth promoting surface is provided as part of a frame (130)configured to be attached to injection port (26). Frame (130) includes abottom surface (132) having a central aperture (134) therein. In theexample shown, the tissue in-growth promoting surface comprises asurgical mesh layer (e.g., polypropylene mesh, etc.) (136) positionedwithin central aperture (134). Mesh layer (136) may be secured withincentral aperture (134) in a variety of ways, such as by insert moldingframe (130) around mesh layer (136). Alternatively, mesh layer (136) mayeven be secured over aperture (134) such as by affixing mesh layer (136)to the bottom surface (132) of frame (130) over central aperture (134).When frame (130) is attached to injection port (26), mesh layer (136)provides a tissue in-growth promoting surface on the underside of port(26). Of course frame (130) may be configured to provide one or moretissue in-growth promoting surfaces at a variety of other locations(e.g., about the outer sidewall of frame (130), etc.).

Frame (130) may be configured to be attached to injection port (26) in avariety of ways. By way of example, frame (130) may be attached to theinjection port using a suitable adhesive. As yet another alternative,frame (130) and injection port (26) may be configured such that frame(130) may be attached to port (26) using a hook and loop fastenerarrangement (e.g., hook members provided on a bottom surface of port(26) and mating hoops on a surface of frame (130)). In the exampleshown, frame (130) is configured to be snap fit over a portion ofinjection port (26). In particular, frame (130) includes a cylindricalchamber (138) located above mesh layer (136). Cylindrical chamber (138)includes a bottom surface (140) and an annular ledge (142) extendingabout bottom surface (140). When frame (130) is attached to injectionport (26) as shown in FIG. 21, annular ledge (142) provides additionalspace between the bottom surface of port (26) and bottom surface (140)of frame (130) as well as mesh layer (136). This additional space allowsfor greater tissue in-growth between port (26) and frame (130), furthersecuring injection port (26) within a patient.

Cylindrical chamber (138) is sized to receive port body (32) therein. Aretention lip (144) is provided about the upper end of chamber (138),and is configured to retain port body (32) within chamber (138). A pairof cutouts (146, 148) are also provided in the outer wall of chamber(138) in order to accommodate extensions (88, 89) on port body (32).Cutouts (146, 148) also facilitate the attachment of frame (130) to portbody (32) by allowing the upper end of frame (130) to be flexedoutwardly. In this manner, frame (130) may be snap-fit over port body(32) with retention lip (144) pressed against an upper end surface ofport body (32). A plurality of slots (156) are also provided in thebottom of frame (130). Slots (156) are configured and located to allowfasteners (34) to be deployed therethrough.

While frame (130) is configured to snap-fit over port body (32) suchthat mesh layer (136) is positioned adjacent the bottom of the injectionport (26), the frame may have any of a variety of alternativeconfigurations. For example, the frame may be configured to snap fitover the top of injection port (26) such that the mesh layer coversseptum (28). Such an arrangement may be desirable in that the injectionport (26) may first be secured within a patient (e.g., using fasteners(34)), and thereafter the mesh containing frame may be snap fit over thetop of the injection port such that the surgical mesh layer coversseptum (28) and/or is adjacent to septum (28). As withpreviously-described example, the mesh layer may be configured so as tonot interfere with the insertion of a needle into septum (28), and mayeven be configured to provide tactile feedback. As yet anotheralternative, the frame may be configured to fit over the top and bottomof injection port (26)—e.g., a two part frame arranged similar to aclamshell. In such an arrangement, mesh layers may be provided beneaththe injection port as well as over septum (28) or adjacent to septum(28).

In place of mesh layer (136), or in addition thereto, frame (130) may beconfigured similar to the previously described examples having one ormore tissue in-growth promoting surfaces on the injection port. Forexample, portions of the bottom surface and/or outer peripheral sidewallof frame (130) may be textured in order to promote tissue in-growth.Such texturing may comprise, for example, one or more recesses,apertures, passageways, interconnected pores (i.e., a porous surface),ridges, protuberances (e.g., a roughened surface), trabeculae, or acombination of one or more of these features. In some versions, aplurality of recesses similar to recesses (100) in FIG. 14 may beprovided on the bottom surface (132) and/or outer peripheral sidewall offrame (130). In addition, a surgical mesh or fabric may be secured oversuch recesses, similar to the example shown in FIG. 12.

As yet another merely illustrative alternative, frame (130) may have oneor more tissue in-growth promoting materials such as surgical meshbonded to the bottom surface (132) and/or outer peripheral sidewall offrame (130). Such tissue in-growth promoting material may, for example,take the form of a section of polypropylene mesh bonded to frame (130)so as to extend about the outer peripheral sidewall of frame (130)similar to the example shown in FIG. 5.

2. Ring-Shaped Frame Attachable to Injection Port

FIGS. 23-25 depict another example of a frame attachable to an injectionport, where the frame includes a tissue in-growth promoting material. Inthis example, the frame comprises a ring-shaped member (156) having asurgical mesh layer (160) (e.g., polypropylene mesh) mounted within theinterior of ring-shaped frame (156). Frame (156) may be made from any ofa variety of materials, such as plastic suitable for implantation in apatient (e.g., injection molded thermoplastic or thermoset polymer,rigid or semi-rigid, etc.). In the present example, frame (156)comprises a flexible fabric having a plurality of loops (158) on atleast the upper surface of frame (156). Loops (158) are configured forsecuring frame (156) to an injection port having corresponding hookmembers on a surface thereof, thus providing a hook and loop fasteningarrangement. It will be understood that loops (158) may be integrallyformed with the fabric that forms frame (156); or loops (158) may beprovided by a separate layer of material attached to frame (156).

As best seen in FIG. 24, the bottom surface of port base (30) includes aring-shaped region (162) comprising a plurality of polymeric hooks (164)configured for attaching frame (156) to the bottom surface of port base(30). Since the hooks (164) extend away from the bottom surface of portbase (30), when ring-shaped frame (156) is attached to the port (asshown in FIG. 25) mesh layer (160) is spaced away from the bottomsurface of port base (30). Such spacing allows for additional tissuein-growth between mesh layer (160) and the bottom surface of port base(30). If desired, ring-shaped frame (156) also may be thicker than meshlayer (160) such that, when frame (156) is attached to the injectionport, additional space is provided between mesh layer (160) and thebottom of the injection port to allow for even greater tissue in-growth.

It will be understood that the arrangement of the hook and loop fastenersystem may be reversed such that the loops are provided on port base(30) and the hooks are located on frame (156). Also, In addition,fastening systems or arrangements other than a conventional hook andloop fastener system may be used, such as mechanical fastening systemsthat allow frame (156) to be removably attached to port base (30) bypressing frame (156) against port base (30). By way of example, afastening system employing interlocking mushroom-shaped stems sold underthe name DUALLOCK™ by 3M may be employed. As yet another alternative,barb members may be provided on port base (30) in place of hooks orloops. Such barb members may engage frame (156) in order to retain frame(156) on port base (30). Such barb members may also be configured topenetrate the patient's fascia or other tissue at the implantation sitein order to further retain the port in position. The barb members mayeven be made of a bio-absorbable material such that they are absorbedafter sufficient tissue in-growth has occurred. As yet another merelyillustrative alternative, frame members having one or more mesh layersmay be provided for attachment to the injection port at various otherlocations (e.g., over septum (28) and/or adjacent to septum (28), etc.).

IV. Injection Port with Tissue in-Growth Promoting Feature Associatedwith Attached Catheter

Previously-described examples promoted tissue in-growth about variousregions or portions of an injection port in order to substantiallyprevent dislodgement or displacement, and/or limit the mobility of aninjection port, such as an injection port of a gastric band system. Insome instances it may be desirable to promote tissue growth around oralong a catheter attached to an injection port and implanted within apatient in order to substantially prevent catheter disconnect and/orprotect the catheter from damage (e.g., inadvertent needle puncture ofthe catheter when attempting to insert a needle into the septum of theinjection port) or kinking, etc.

Any of the previously-described examples may be adapted to provide oneor more tissue in-growth promoters on, along, adjacent or about acatheter attached to an injection port, with or without a tissuein-growth promoter also provided on or associated with the injectionport itself. For example, a tissue in-growth promoting mesh may beintegrally provided on at least a portion of the outer surface of thecatheter and/or a connector used to attach the catheter to the injectionport (e.g., connector (68) in FIG. 5) and/or a strain relief sleeve orsimilar structure used to protect or maintain attachment of the catheter(e.g., sleeve (70) in FIG. 5). Such mesh may be integrally provided onthe catheter and/or connector using a bicopompatible adhesive, heatstaking, vibration welding, ultrasonic welding, hot/cold upset,mechanical attachment, insert-molding, over-molding, and other waysknown to those skilled in the art. Additional examples of ways in whichtissue growth may be promoted around a catheter will be described ingreater detail below, while other examples will be apparent to those ofordinary skill in the art in view of the teachings herein.

A. Surgical Mesh Wrapped Around Catheter

FIGS. 26-27 depict an exemplary tissue in-growth promoting surgical meshstructure (e.g., polypropylene, etc.) (170) having a first portion(172), a second portion (174) and a connector portion (176) thatconnects first portion (172) with second portion (174). It will beunderstood that connector portion (176) may be omitted, such that firstportion (172) and second portion (174) are contiguous. First portion(172) of this example is configured similar to mesh disc (102) shown inFIGS. 15-16. Thus, first portion (172) of mesh (170) may be positionedbetween port base (30) and port body (32) directly above septum (28),such that first portion (172) will be trapped between port base (30) andport body (32), with a center portion (178) of first portion (172)overlying septum (28). As best seen in FIG. 27, first portion (172) issized such that when trapped between port base (30) and port body (32),an outer annular portion (182) of first portion (172) extends outward ofthe injection port around the lower periphery of port body (32). Whenthe injection port of FIG. 27 is implanted in a patient, center portion(178) of first portion (172) of mesh (170), as well as outer annularportion (182) will be exposed such that tissue may grow into and aroundthese exposed portions of mesh (170). Also, the exposed annular portion(182) of mesh (170) extending away from port body (32) may be used tofurther secure the port within a patient such as by suturing or tackingexposed portion (182) to the fascia or other tissue in the patient.

Like the example shown in FIG. 15, first portion (172) of mesh (170) isconfigured to have regions of varying density (in terms of weight, meshsize, and/or thickness). In the example shown in FIGS. 26-27, centerportion (178) has a greater density than the outer portion (180).Alternatively, outer portion (180) may be configured to have a greaterdensity than center portion (178), as described previously. Centerportion (178) of mesh (170) may even be eliminated entirely such thatfirst portion (172) of surgical mesh (170) forms an annulus.

While first portion (172) of surgical mesh (170) is used to help secureinjection port (26) within a patient (e.g., by tissue growth into themesh), second portion (174) of surgical mesh (170) is configured to wraparound catheter (18) as shown. Second portion (174) is wrapped aroundcatheter (18) in overlapping fashion, as shown in FIG. 27, and extendsalong a portion of the length catheter (18) beyond sleeve (70).Alternatively, second portion (174) of mesh (170) may be wrapped aroundcatheter (18) in a spaced apart-fashion such that gaps are providedbetween adjacent revolutions of second portion (174). A portion of thedistal end (184) of second portion (174) is tucked under the adjacentrevolution of second portion (174) in order to secure second portion(174) wrapped around catheter (18). Alternatively, or in additionthereto, second portion (174) may be secured to at least a portion ofcatheter (18) using a suitable adhesive, or other means known to thoseskilled in the art.

When the injection port shown in FIG. 27 is implanted in a patient,first and second portions (172, 174) of surgical mesh (170) will allowfor tissue growth into and around the mesh. Such tissue in-growth maynot only help substantially maintain injection port (26) in place, butmay also substantially prevent catheter (18) from becoming disconnectedfrom the injection port. In addition, particularly if at least secondportion (174) of mesh (170) is made from a sufficiently dense material,inadvertent puncture of catheter (18) may be substantially prevented.Furthermore, the strength of second portion (174) and/or the additionalstructural support provided by tissue growing in/around second portion(174) may substantially reduce the likelihood of catheter (18) kinkingor tearing near port (26).

Second portion (174) of surgical mesh (170) may be provided in any of avariety of lengths and widths. In fact, second portion (174) may besufficiently long so as to be wrapped around the entire length ofcatheter (18). In addition, second portion (174) may be wrapped aroundnot only a portion of catheter (18), but also around extension (88) onport body (32) and/or additional portions of sleeve (70) in order tofurther prevent catheter disconnect.

In addition, second portion (174) of surgical mesh (170) may be usedwith any of the previously-described examples. For instance, an elongatestrip of surgical mesh similar to second portion (174) may be attachedto frame (130) in FIG. 20 or frame (156) in FIG. 23 so as to extend awayfrom the frame (130, 156). When either of these frames (130, 156) isattached to an injection port in the manner previously described, theelongate strip of surgical mesh extending from the frame (130, 156) maybe wrapped around the catheter similar to what is shown in FIG. 27. Itis even contemplated that an elongate strip of surgical mesh similar tosecond portion (174) in FIG. 26 may simply be wrapped around the fluidconduit to promote tissue in-growth. If desired, one end of such anelongate strip may be attached to the injection port using, for example,an adhesive. In addition, the surgical mesh may be wrapped around atleast a portion of the catheter where the catheter is attached to theinjection port (e.g., around sleeve (70), etc.).

B. Pleated Surgical Mesh Associated with Catheter

FIGS. 28-29 depict another example of a tissue in-growth promotingsurgical mesh (e.g., polypropylene, etc.) (190) that includes a catheterdisconnect prevention portion. In this example, surgical mesh (190) hasa first portion (192) configured for attachment to the bottom ofinjection port (26). First portion (192) may be configured similar tofirst portion (172) in FIG. 26, and may be trapped between components ofthe injection port such that a region of first portion (192) is exposedfor tissue in-growth. In the example shown, however, first portion (192)comprises a disc-shaped member configured to be attached to the bottomsurface of injection port (26) by using a suitable adhesive.Alternatively, first portion (192) may be attached to the bottom surfaceof port (26) using hook and loop fasteners, sutures, or any of a varietyof other fastening means. As yet another alternative, first portion(192) may simply be positioned beneath injection port (26) in a patientsuch that when fasteners (34) are deployed to secure port (26) in place,first portion (192) of mesh (190) will be secured in place between port(26) and the patient's tissue by fasteners (34).

Also in the present example, first portion (192) of surgical mesh (190)is slightly larger than the bottom surface of injection port (26) suchthat an annular region (200) of first portion (192) extends beyond theouter periphery of port (26). This exposed annular region (200) not onlyprovides an area for additional tissue in-growth, it may also be securedwithin a patient using sutures, staples, surgical tacks, or otherfasteners.

Second portion (194) of surgical mesh (190) is connected to firstportion (192) by connector portion (196), which is attached to a firstend of second portion (194). Once again it will be understood thatconnector portion (196) may be omitted, such that first portion (192)and second portion (194) are contiguous. While second portion (194)comprises an elongate strip of mesh similar to second portion (174) inFIG. 26, second portion (194) of FIGS. 28-29 further includes aplurality of apertures (198) extending through the mesh along the lengthof second portion (194). In the embodiment shown, each aperture (198) islocated centrally in the width direction of second portion (194), andapertures (198) are substantially evenly spaced along substantially theentire length of second portion (194). Of course, this is merely oneexemplary configuration, as any of a variety of alternative arrangementsof apertures (198) may be provided.

Second portion (194) of surgical mesh (190) is configured such thatcatheter (18) is threaded through each of apertures (198), resulting inthe pleating of second portion (194), as shown in FIG. 29. Thus,catheter (18) extends through apertures (198) in adjacent pleats. Byproviding a pleated surgical mesh along at least a portion of the lengthof catheter (18), greater mesh surface area for tissue in-growth isprovided. If desired, a suitable adhesive may be used to secureapertures (198) to the outer surface of catheter (18) or even sleeve(70) if desired.

Second portion (194) of surgical mesh (190) may be provided in any of avariety of lengths and widths. In fact, second portion (194) may besufficiently long so as to extend along the entire length of catheter(18). In addition, second portion (194) may be provided about not only aportion of catheter (18), but also about extension (88) on port body(32) and/or additional portions of sleeve (70) in order to furtherprevent catheter disconnect.

In addition, second portion (194) of surgical mesh (190) may be usedwith any of the previously-described examples. For instance, anapertured elongate strip of surgical mesh similar to second portion(194) may be attached to frame (130) in FIG. 20 or frame (156) in FIG.23 so as to extend away from the frame (130, 156). When either of theseframes (130, 156) is attached to an injection port in the mannerpreviously described, the catheter (18) may be threaded through thepleated strip of surgical mesh extending from the frame (130, 156) in amanner similar to that shown in FIG. 29. It is even contemplated that apleated and apertured elongate strip of surgical mesh similar to secondportion (194) in FIG. 28 may be use by itself to promote tissuein-growth around the fluid conduit of an implanted injection port. Ifdesired, a first end of such a pleated strip may be attached to theinjection port using, for example, an adhesive. In addition, the pleatedsurgical mesh may extend about at least a portion of the catheter wherethe catheter is attached to the injection port (e.g., adjacent sleeve(70), as shown in FIG. 29).

C. Frame Having Catheter Disconnect Prevention Portion

FIG. 30 depicts yet another example of an arrangement for providing atissue in-growth promoter for preventing catheter disconnect. In thisexample, a catheter disconnect prevention portion comprising retentionmember (246) is provided on a frame (230) configured to be attached toinjection port (26) described previously. Retention member (246)includes one or more mesh layers (254). Frame (230) is configured suchthat when attached to injection port (26), mesh layers (254) are locatedso as to provide a tissue in-growth promoting surface adjacent at leasta portion of a catheter attached to injection port (26).

Frame (230) is configured similar to frame (130) described previously,and thus includes a bottom surface (232) having a central aperture (234)therein. A surgical mesh layer (e.g., polypropylene mesh, etc.) (236) ispositioned within central aperture (234). It will be understood,however, that central aperture (234) and mesh layer (236) may be omittedfrom this example. Mesh layer (236) may be secured within centralaperture (234) in a variety of ways, such as by insert molding frame(230) around mesh layer (236). When frame (230) is attached to injectionport (26), mesh layer (236) provides a tissue in-growth promotingsurface on the underside of port (26). Of course frame (230) may beconfigured to provide one or more tissue in-growth promoting surfaces ata variety of other locations (e.g., about the outer sidewall of frame(230), etc.).

Frame (230) may be configured to be attached to injection port (26) in avariety of ways. By way of example, frame (230) may be attached to theinjection port using a suitable adhesive. As yet another alternative,frame (230) and injection port (26) may be configured such that frame(230) may be attached to port (26) using a hook and loop fastenerarrangement (e.g., hook members provided on a bottom surface of port(26) and mating hoops on a surface of frame (230)). In the exampleshown, frame (230) is configured to be snap fit over a portion ofinjection port (26), in the manner described previously with respect toframe (130) shown in FIGS. 20-22.

Retention member (246) extends away from sidewall (231), which defines acylindrical chamber portion of frame (230). Retention member (246)includes a first portion (252) and a second portion (253). Retentionmember (246) is further configured such that when frame (230) isattached to port (26), first portion (252) extends along and partiallyaround extension (88) on port (26) and second portion (253) extendsalong and partially around sleeve (70). In this manner, retention member(246) extends along and partially around catheter (18) attached to port(26) (since catheter (18) extends through sleeve (70) and extension(88)), and mesh layers (254) provide tissue in-growth promoting surfacesfor retaining catheter (18) to port (26).

While frame (230) is configured to snap-fit over port body (32) suchthat retention member (246) extends along and partially around extension(88) and sleeve (70) of port (26), the frame may have any of a varietyof alternative configurations. For example, retention member (246) maybe configured as a flat plate (or similar arrangement) that extendsalong the bottom surface of extension (88) and sleeve (70) rather than agenerally U-shaped member as depicted. In addition, retention member(246) may include a single U-shaped portion rather than first and secondportions configured to separately and matingly receive extension (88)and sleeve (70) of port (26). Also, mesh layers (254) may be provided onretention member (246) in any of the variety of ways previouslydescribed (e.g., insert molding about a mesh fabric or rigid plasticscreen, etc.).

In place of mesh layers (254), or in addition thereto, frame (230) maybe configured similar to the previously described examples having one ormore tissue in-growth promoting surfaces on the injection port. Forexample, portions of the bottom surface and/or outer peripheral sidewallof retention member (246) may be textured in order to promote tissuein-growth. Such texturing may comprise, for example, one or morerecesses, apertures, passageways, interconnected pores (i.e., a poroussurface), ridges, protuberances (e.g., a roughened surface), trabeculae,or a combination of one or more of these features. In some versions, aplurality of recesses similar to recesses (100) in FIG. 14 may beprovided on the bottom surface and/or outer peripheral sidewall ofretention member (246). In addition, a surgical mesh or fabric may besecured over such recesses, similar to the example shown in FIG. 12. Asyet another merely illustrative alternative, frame (230) may have one ormore tissue in-growth promoting materials such as surgical mesh bondedto the bottom surface and/or outer peripheral sidewall of retentionmember (246) similar to the example shown in FIG. 5.

It will be understood that the examples shown and described herein aremerely exemplary, and may be modified by those skilled in the art. Forexample, biocompatible adhesives may be applied to an injection portand/or tissue in-growth promoting surfaces in order to further securethe port and/or fluid conduit in place. In addition, antimicrobialcoatings may be applied to the surgical mesh and/or other portions of aninjection port or fluid conduit. It should also be understood thattissue in-growth promoting features as described herein may beincorporated into virtually any type of implanted device. The abovedescribed examples of gastric band systems are mere illustrations. Theinventors' contemplation is not limited to components of gastric bandsystems. By way of example only, tissue in-growth promoting features asdescribed herein may be incorporated into an implanted drug infusionport, chemotherapy port, or any other type of implantable port that isused to deliver something to a patient (e.g., an injection, treatment,medication, etc.), to help a physician locate the implanted port throughpalpation of the patient. Still other types of implanted devices thatmay incorporate tissue in-growth promoting features as described hereinwill be apparent to those of ordinary skill in the art in view of theteachings herein.

It will become readily apparent to those skilled in the art thatexamples described herein may have applicability to other types ofimplantable bands. For example, bands are used for the treatment offecal incontinence. One such band is described in U.S. Pat. No.6,461,292, entitled “Anal Incontinence Treatment with Wireless EnergySupply,” issued Oct. 8, 2002, the disclosure of which is incorporated byreference herein. Bands can also be used to treat urinary incontinence.One such band is described in U.S. Pat. No. 7,621,863, entitled “UrinaryIncontinence Treatment with Wireless Energy Supply,” issued Nov. 24,2009, the disclosure of which is incorporated by reference herein. Bandscan also be used to treat heartburn and/or acid reflux. One such band isdescribed in U.S. Pat. No. 6,470,892, entitled “Mechanical Heartburn andReflux Treatment,” issued Oct. 29, 2002, the disclosure of which isincorporated by reference herein. Bands can also be used to treatimpotence. One such band is described in U.S. Pat. No. 7,442,165,entitled “Penile Prosthesis,” issued Oct. 28, 2008, the disclosure ofwhich is incorporated by reference herein. Various ways in which theteachings herein may be incorporated with the teachings of these patentreferences will be apparent to those of ordinary skill in the art.

Versions of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. A surgically implantable injection port, comprising: (a)a housing, wherein the housing comprises a top, a bottom, a side, a portbody, and a port base, wherein the side comprises one or more sidesurfaces oriented circumferentially around the housing; (b) a fluidreservoir defined in part by the housing; (c) a needle penetrable septumhaving an outer surface, wherein the septum defines part of the fluidreservoir such that the reservoir is configured to receive part of aneedle inserted through the outer surface of the septum, wherein theouter surface of the septum is unobstructed by the housing; and (d) atissue in-growth promoting surface integrally provided on at least oneexterior side surface of the housing, wherein the tissue in-growthpromoting surface comprises: (i) a plurality of recesses integrated intothe housing, the plurality of recesses forming a textured region forpromoting tissue in-growth, wherein the plurality of recesses are rigid,wherein the plurality of recesses define a matrix grid, wherein eachrecess of the plurality of recesses comprises an interior surface offsetinwardly from an exterior of the side surface of the housing, whereineach recess of the plurality of recesses shares a common border with atleast one other recess of the plurality of recesses, wherein theinterior surface of each recess comprises a plurality of apertures,passageways, interconnected pores, ridges, or protuberances, and (ii) asurgical mesh at least partially attached to the housing, wherein thesurgical mesh completely covers the plurality of recesses and therebydefines a pocket between the surgical mesh and the interior surface ofindividual recesses, wherein the surgical mesh is mounted at leastpartially within the housing, wherein part of the surgical mesh extendsover the outer surface of the septum, wherein a first portion of thesurgical mesh has a different density than a second portion of thesurgical mesh, wherein the first portion and the second portion of thesurgical mesh are configured to provide a tactile response whenpenetrated with a needle, wherein the second portion of surgical meshcircumscribes the outer perimeter of the first portion of the surgicalmesh, wherein the surgical mesh is mounted between the port body and theport base of the housing.
 2. The injection port of claim 1, wherein thesurgical mesh comprises a biocompatible material.
 3. The injection portof claim 1, wherein a portion of the surgical mesh extends away from thehousing about at least a portion of an outer perimeter of the housing.4. The injection port of claim 1, further comprising: (a) a gastric bandhaving an inflatable member; and (b) a catheter coupling the reservoirwith the inflatable member, wherein the reservoir, the catheter, and theinflatable member together form a closed fluid circuit, wherein a thirdsurgical mesh portion connects to and extends radially from the secondsurgical mesh portion, wherein the third surgical mesh comprises aplurality of apertures, wherein the catheter extends through theplurality of apertures in such a way that the third surgical meshportion is associated with the length of the catheter.
 5. The injectionport of claim 1, wherein the bottom of the fluid reservoir comprises ofa plate between the plurality of recesses integrated into the port baseof the housing and the fluid reservoir, wherein the plate is secured tothe port base, wherein the plate is configured to prevent a needle frompuncturing through the port base.
 6. A surgically implantable injectionport, comprising: (a) a housing, wherein the housing comprises a base;(b) a fluid reservoir defined in part by the housing, wherein aninterior surface of the base defines a bottom of the fluid reservoir;(c) a needle penetrable septum, wherein the septum defines part of thefluid reservoir such that the reservoir is configured to receive part ofa needle inserted through the septum; (d) a catheter attached to thehousing in communication with the reservoir; and (e) a frame, whereinthe frame is attached to the port housing, wherein one or both of thehousing or the frame comprise a tissue in-growth promoting surfacelocated on a plane oriented perpendicular to the interior surface of thebase, wherein the frame is snap fit over a portion of the housing,wherein the frame is attached to the bottom of the housing, and whereinthe tissue in-growth promoting surface is formed at least in part by atleast: (i) a textured region, where the textured region is on anexterior surface of the base of the housing, wherein the textured regioncomprises a matrix grid defining a plurality of recesses, wherein eachindividual recess comprises an interior surface, and (ii) a surgicalmesh having antimicrobial properties, wherein the textured region isfully covered by the surgical mesh, wherein the surgical mesh extendsalong a plane oriented perpendicular to the interior surface of thebase, wherein the frame is ring-shaped with the surgical mesh alsoextending across an open center of the frame, wherein part of thetextured region defines an aperture extending radially from thering-shaped frame configured to sheath a portion of the catheterattached to the housing, wherein the bottom of the fluid reservoircomprises of a plate between the tissue in-growth promoting surface andthe fluid reservoir, wherein the plate is secured to the base, whereinthe plate is configured to prevent a needle from puncturing the base.